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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
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The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone(CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDD Plus Bortezomib | Experimental | Patients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity. |
|
| CDD | Active Comparator | Dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDD | Drug | Chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with overall hematologic response | Complete response, very good partial response and partial response | Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with EMP response | response rate | Assessed every 2 cyeles period is projected to be approximately 24 months |
| Overall survival | The median overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuping ZHONG, Doctor | Contact | 861051718999 | zhongyp3352@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuping Zhong, Doctor | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuping ZHONG | Recruiting | Beijing | Beijing Municipality | 100043 | China |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| CDD Plus Bortezomib | Drug | Chemotherapy plus Proteasome Inhibitors |
|
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| Monthly up to 3 years |
| Time from diagnosis ofEMP to the date of death | Monthly up to 3 years |
| Progression free survival | Monthly up to 2 years |
| Time from date of diagnosis of EMP to the date of first documentation of disease | Monthly up to 2 years |
| Number of adverse events | Adverse events, serious adverse events, assessment of clinical laboratory values from the date of signing of the informed consent form through 30 days after the last dose of study drug. | Monthly up to 3 years |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |